This application requests support for a web-based IRB protocol and tracking system. The system will provide for the electronic submissions of protocols; all subsequent investigator, IRB, and institutional actions; management of all IRB activities; integration of interfaces with other institutional units; tracking and generation of reports for both internal and external use; and archiving and permanent retention of protocols and related records. Funds are requested for software and hardware, personnel for initial implementation and training, and information technology (IT) support personnel during the year of the award. After the 1-year award period, the institution will provide ongoing support for IT personnel needs of the Office of Research Support Committees, which supports the Committee for the Protection of Human Subjects (CPHS) that serves as our Institutional Review Board (IRB). The requested system will serve the 9 schools and operating units of The University of Texas Health Science Center at Houston (UTHSC-H), one of the largest and most comprehensive academic health centers in the world. In FY 2001, the UTHSCH-H had total research expenditures of approximately $120 million, of which 56% involved human subjects. The requested system will be part of our comprehensive program which has the overall goals of emphasizing the protection of human subjects through proper research design and planning to prevent errors, rather than after-the-fact audits and sanctions, while simultaneously improving the quality of the research itself. The program will be under the direction of the Executive Vice President for Research of the UTHSC-H.
